Closure device with string retractable umbrella and method for closing a body opening with the same

ABSTRACT

A method for closing a body opening in a patient is disclosed. The method comprises positioning a delivery catheter within the body opening. The delivery catheter includes a closure device comprising a distal occluding body and a proximal occluding body. The closure device is collapsibly disposed within a distal end of the delivery catheter. The method further includes deploying the closure device from the delivery catheter about the body opening such that a distal frame of the distal occluding body expands to its expanded configuration at a distal end of the body opening and a proximal frame of the proximal occluding body expands to its expanded configuration at an opposing proximal end of the body opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application No.12/404,652, filed Mar. 16, 2009, entitled “CLOSURE DEVICE WITH STRINGRETRACTABLE UMBRELLA”, which is hereby incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to closure devices. Morespecifically, the invention relates to a closure device for closingphysical apertures, such as vascular or septal apertures.

2. Description of Related Art

The heart is generally comprised of four chambers: the left and rightatrium and left and right ventricle. Separating the left and right sidesof the heart are two walls, or septa. The wall between the two atria isthe interatrial septum, and the wall between the two ventricles is theinterventricular septum. There are several defects which can affect thesepta of both children and adults, including patent ductus arteriosus,patent foramen ovale (PFO), arterial septal defects (ASDs), andventricular septal defects (VSDs). Although the causes and physicalcharacteristics of these defects vary by type, each of these defects isgenerally an aperture, flap, or hole in the septum which allows blood toshunt between chambers in the heart where there is no blood flow in anormal, healthy heart. This abnormal shunt can cause a variety ofproblems.

Normally, permanently repairing certain cardiac defects in adults andchildren requires open heart surgery, which is a risky, painful, andexpensive procedure. Surgery for closure of a heart defect is majorheart surgery, which requires the patient to undergo general anesthesiaand opening of the chest cavity. The patient must spend several days inthe hospital and takes several weeks to be able to return to normallevels of activity.

To avoid the risks and discomfort associated with open heart surgery,modern occlusion or closure devices have been developed that are small,implantable, and capable of being delivered to the heart through acatheter. Rather than surgery, a catheter inserted into a major bloodvessel allows an occlusion device to be deployed by moving the devicethrough the catheter to the treatment site within the body. Thisprocedure is performed in a cardiac cathlab and avoids the risks, pain,and long recovery associated with open heart surgery.

There are currently several types of closure devices capable of beinginserted via a catheter including button devices, collapsibleumbrella-like structures, and plug-like devices. These modem closuredevices can repair a wide range of cardiac defects, including patentforamen ovale, patent ductus arteriosus, atrial septal defects,ventricular septal defects, and may occlude other cardiac andnon-cardiac apertures. Many of the conventional closure devices can betechnically complex, bulky and difficult to deploy in a preciselocation. In addition, such devices may be difficult or impossible toretrieve and/or reposition should initial positioning not besatisfactory.

SUMMARY OF THE INVENTION

In satisfying the above need, as well as overcoming the enumerateddrawbacks and other limitations of the related art, the presentinvention provides a closure device for occluding a body opening.

In one embodiment, the closure device includes distal and proximaloccluding bodies having expandable distal and proximal umbrella frames,respectively. The distal frame is attached at its center to a distal endof a center rod, the distal frame including a plurality of struts havingfirst ends attached to the distal end of the center rod. The proximalframe is slidable along the center rod, which defines a longitudinalaxis, via a center ring. The proximal frame includes a plurality ofstruts having first ends attached to the center ring. The struts of eachframe are connected to a biocompatible sheet material which engages thebody tissue defining the body opening when the distal and proximalframes are in expanded configurations.

In this embodiment, the distal frame struts extend from the distal endof the center rod in a generally parallel, axial direction with respectto the longitudinal axis when the distal frame is in a collapsedconfiguration and in a generally perpendicular, radial direction withrespect to the longitudinal axis when the distal frame is in theexpanded configuration. The proximal frame struts extend from the centerring in a generally parallel, axial direction with respect to thelongitudinal axis when the proximal frame is in a collapsedconfiguration and in a generally perpendicular, radial direction withrespect to the longitudinal axis when the proximal frame is in theexpanded configuration. The distal and proximal frames expand to theirexpanded configurations on opposite sides of the body opening.

In this embodiment, each strut of the distal frame extends from thefirst end and terminates with an eyelet. A drawstring is threadedthrough the eyelets of the distal frame and through the center ring ofthe proximal frame to connect the distal and proximal occluding bodiesto one another. The drawstring extends proximally from the center ringand manipulation of the center rod and the drawstring is configured tomove the distal and proximal frames from their expanded configurationstoward their collapsed configurations for at least partial retrieval ofthe closure device to more optimally position the closure device.

In another embodiment, a first drawstring is threaded through theeyelets of the distal frame and through the center ring of the proximalframe to connect the distal and proximal occluding bodies to one anotherand a second drawstring extends proximally from the center ring. In thisembodiment, manipulation of the center rod and the second drawstring isconfigured to move the distal and proximal frames from their expandedconfigurations toward their collapsed configurations for at leastpartial retrieval of the closure device to more optimally position theclosure device.

In another embodiment, a closure device assembly includes a closuredevice, as described above, collapsibly disposed within the distal endof a delivery catheter. The closure device assembly further includes agrasping instrument for manipulating the drawstring extending proximallyfrom the center ring.

In another embodiment, a method for closing a body opening in a patientcomprises positioning a delivery catheter within the body opening, thedelivery catheter including a closure device, as described above,collapsibly disposed within the distal end of the delivery catheter. Themethod further includes deploying the closure device from the deliverycatheter about the body opening such that the distal frame of the distaloccluding body expands to its expanded configuration at a distal end ofthe body opening and the proximal frame of the proximal occluding bodyexpands to its expanded configuration at an opposing proximal end of thebody opening.

Further objects, features, and advantages of the present invention willbecome apparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a human heart including variousseptal defects;

FIG. 2 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device frame shown inan expanded configuration;

FIG. 3 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device shown in acollapsed delivery configuration;

FIG. 4 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device shown in apartially deployed configuration;

FIG. 5 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device shown in aretrievable deployed configuration;

FIG. 6 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device shown in apartially retrieved configuration;

FIG. 7 is a side view of a closure device assembly according to anembodiment of the present invention, the closure device shown in a fullydeployed configuration; and

FIG. 8 is a flowchart for a method of closing a body opening of apatient.

DETAILED DESCRIPTION

FIG. 1 is a schematic front view of a human heart 1, having a rightatrium 2 and a left atrium 4 and including various anatomical anomalies9 a and 9 b. The atrial septum 6 between the right atrium 2 and the leftatrium 4 comprises a septum primum 7 and a septum secundum 8. Theanatomy of the septum 6 varies widely within the population. In somepeople, the septum primum 7 extends to and overlaps with the septumsecundum 8. The septum primum 7 may be quite thin. When anatomicalanomalies are present, blood could travel through the opening 9 a(referred to as “the PFO tunnel”) or 9 b (referred to as an “ASD”)between septum primum 7 and septum secundum 8.

Referring to FIG. 2, a closure device embodying the principles of thepresent invention is illustrated therein and designated at 10. Theclosure device 10 includes a proximal occluding body 12 formed from anexpandable umbrella frame 14 and an opposing distal occluding body 16formed from an expandable umbrella frame 18. Each of the umbrella frames14, 18 includes a plurality of struts 22, 26. The struts 22 includefirst ends 23 attached to a center ring 25, which is slidable along acenter rod 33, and the struts 26 include first ends 27 fixedly attachedto a distal end 29 of the center rod 33.

In this embodiment, the struts 26 of the distal umbrella frame 18terminate with eyelets 30 through which at least one suture ordrawstring 31 is threaded to form a perimeter about the distal occludingbody 16. The drawstring 31 is threaded through, or tied to, the centerring 25 of the proximal umbrella frame 14, forming a loop connecting theproximal occluding body 12 to the distal occluding body 16. Preferably,the drawstring 31 is made of nylon, polyester, or any other suitablematerial known in the art. The center ring 25 may be made of the samematerial as the drawstring 31 or the struts 22, 26 (as discussed in moredetail below) or any other suitable material in the art.

As illustrated in FIGS. 3-7, the struts 22, 26 of the proximal anddistal occluding bodies 12, 16 are connected to or covered bybiocompatible or bioremodelable sheet materials 32, which include tissuelayers or synthetic polymeric layers formed into a sheet or compositethereof. A sheet of biocompatible or bioremodelable material mayinclude, for example, extracellular matrix tissue, including one or morenaturally-derived tissue layers containing an ECM scaffold, one or morebiocompatible polymeric layers, or combinations thereof. The sheet ofbiocompatible or bioremodelable material can be in the form of a singletissue or polymeric layer or a plurality of tissue or polymeric layersin form of laminates, composites, or combinations thereof.

Preferably, the biocompatible sheet materials 32 include bioremodelablesheet materials, such as collagenous ECM materials. Suitable collagenousECMs include those derived from a variety of native tissues, includingbut not limited to, intestine, stomach, bladder, liver, fascia, skin,artery, vein, pericardium, pleura, heart valve, dura mater, ligament,tendon, bone, cartilage, bladder, liver, including submucosal tissuestherefrom, renal capsule membrane, dermal collagen, serosa, mesenterium,peritoneum, mesothelium, various tissue membranes and basement membranelayers, including liver basement membrane, and the like. Suitablesubmucosa tissue materials for these purposes include, for instance,intestinal submucosa, including small intestinal submucosa (SIS),stomach submucosa, urinary bladder submucosa, and uterine submucosa. Aparticularly preferred ECM material is porcine SIS material.

Further examples of biocompatible or bioremodelable sheet materialsinclude thrombogenic fibrous materials, such as DACRON (DUPONT,Wilmington, Del.), cotton, silk, wool, polyester thread and the like,polyurethanes, and polymeric materials, such as PTFE, ePTFE. Otherexamples of suitable biocompatible or bioremodelable sheet materials andmethods of forming such sheets are described in U.S. patent applicationSer. No. 11/845,423, filed Aug. 27, 2007, inventors Kurt J.Tekulve andDusan Pavcnik, the disclosure of which is expressly incorporated byreference herein.

Biocompatible sheet material 32 may be attached underneath the umbrellaframes 14, 18, over the umbrella frames 14, 18, or combinations thereof.The struts 22, 26 may extend through the biocompatible sheet material 32at one end. Biocompatible or bioremodelable sheet materials 32 may beattached to either side of the struts 22, 26, or both. Biocompatible orbioremodelable sheet materials 32 may be attached to the struts 22, 26by any suitable attachment method, including but not limited to, use ofsutures, chemical cross-linking agents, crimping, tissue welding, heatwelding, pressure welding, heat source, light source, radiofrequency,lasering, other energy sources, and the like. Methods for attachingsheet materials to wires or wired frames are described in U.S. PatentApplication Publication No. 2001/0039450 A1, the disclosures of whichare expressly incorporated by reference herein.

In this embodiment, the umbrella frames 14, 18 are expandable between acollapsed delivery configuration for delivery or at least partialretrieval of the closure device 10 and an expanded configuration formaximizing contact between the biocompatible sheet materials 32 and thebody tissue, such as the septum 6, defining a body passageway or opening9. As used in this application, unless otherwise indicated, the term“body opening 9” refers to any anatomical anomaly or passageway that maybe treated by use of the closure device 10, such as a PFO 9 a, ASD 9 b,VSD (not shown), and/or PDA (not shown).

As depicted in FIG. 2, the struts 22, 26 preferably include an arcuateconformation. In the collapsed delivery configuration, the struts 22extend from the center ring 25 of the proximal umbrella frame 14 in agenerally parallel, axial and distal direction with respect to alongitudinal axis 21 defined by the center rod 33 and the struts 26extend from the distal end 29 of the center rod 33 in a generallyparallel, axial and proximal direction with respect to the longitudinalaxis 21. In the expanded deployed configuration, the struts 22 extendfrom the center ring 25 of the proximal umbrella frame 14 in a generallyperpendicular, radial direction with respect to the longitudinal axis 21and the struts 26 extend from the distal end 29 of the center rod 33 ina generally perpendicular, radial direction with respect to thelongitudinal axis 21.

In this embodiment, the arcuate conformation of the struts 22 extendingfrom the first ends 23 to the second ends 24 is defined by a concavesurface facing the longitudinal axis 21, and extending in a directiontoward the distal occluding body 16 in the collapsed deliveryconfiguration. Similarly, the arcuate conformation of the struts 26extending from the first ends 27 to the eyelets 30 is defined by aconcave surface facing the longitudinal axis 21, and extending in adirection toward the proximal occluding body 12 in the collapseddelivery configuration. The proximal occluding body 12 is configured forplacement at a proximal end 40 of the body opening 9 and the distaloccluding body 16 is configured for placement at a distal end 42 of thebody opening 9, the struts 22, 26 being biased against and engaging theproximal and distal sides of the septum 6, respectively, in the expandeddeployed configuration. Thus, as depicted in FIG. 2, the struts 22 arecurved in a direction toward the struts 26 and the struts 26 are curvedin a direction toward the struts 22 in the expanded deployedconfiguration. In other words, the struts 22 form a distally facingconcave surface and the struts 26 form a proximally facing concavesurface in the expanded configuration.

While FIG. 2 depicts each of the proximal and distal umbrella frames 14,18 of the proximal and distal occluding bodies 12, 16 as having fourstruts 22, 26, the closure device 10 is not so limited. For example, theclosure device 10 may include anywhere between five and ten or morestruts on each umbrella frame 14, 18

Preferably, the closure device 10 of the present invention is made ofsufficiently flexible materials to facilitate collapsible retention anddelivery from a variety of delivery catheter sizes, including 5, 6, 7,or 8 French size delivery catheters having an inner sheath diameterbetween 0.074 inches and 0.113 inches. The closure device 10 ispreloaded at the tip of a delivery catheter in a collapsed, firstconfiguration. When the closure device 10 is expelled from the deliverycatheter, it expands to a second, expanded configuration. Accordingly,the closure device 10 is preferably made from flexible and/or shapememory alloy materials, such as Nitinol.

Shape-memory materials, including Nitinol alloys, may be utilizedwhereby the alloy material(s) is compressed or partially expanded in itsmartensitic state and fully expanded in its austenitic state. Forexample, specific shape memory alloy materials may be chosen so that theclosure device 10, including the struts 22, 26, is in the austeniticstate at body temperature. Prior to insertion into the body, the closuredevice 10 may be maintained at a low temperature within the martensiticrange. Upon delivery to a desired bodily location, the closure device 10may be warmed to at least the A_(f).temperature so that, for example,the struts 22, 26 expand to their desired configuration. Preferably, thestruts 22, 26 are formed from a superelastic material, stainless steelwire, Nitinol, cobalt-chromium-nickel-molybdenum-iron alloy, or cobaltchrome-alloy, or any other suitable material that will result in aself-opening or self-expanding umbrella frame.

In one embodiment, the umbrella frames 14, 18 may be provided with aradiopaque coating, such as gold or platinum in order to enhanceradiopacity so that the frame can be viewed remotely during deployment.Alternatively, radiopaque marker bands may be employed.

FIG. 3 depicts a closure device assembly 60 facilitating deployment ofthe closure device 10. As illustrated, the closure device assembly 60includes a delivery catheter 50 containing a preloaded, collapsiblydisposed closure device 10 disposed within the lumen of the deliverycatheter 50, at the distal end of the delivery catheter 50. In thisembodiment, the proximal occluding body 12 is slidable along the centerrod 33, via the center ring 25, such that the proximal occluding body 12is slidable to a position sufficiently proximal from the distaloccluding body 16 to prevent the proximal and distal occluding bodies12, 16 from interfering with one another in their collapsedconfigurations. Thus, there is a distance along the center rod 33between the second ends 24 of the struts 22 and the eyelets 30 of thestruts 26 in the collapsed delivery configuration.

In this embodiment, the center rod 33 extends proximally from the distalend 29 and through the proximal end of the catheter 50 for manipulationof the center rod 33, and thus the distal occluding body 16, by aphysician. Preferably, the drawstring 31 is threaded through, or tiedto, the center ring 25 of the proximal umbrella frame 14 such that atleast a portion of the drawstring 31 extends proximally from the centerring 25 of the proximal umbrella frame 14. Preferably, the tail ends 34(i.e., small portions of each end) of the drawstring 31 extendproximally from the center ring 25. The closure device assembly 60preferably includes a grasping device, such as a bioptome 46, having agrasping portion 43 to grasp the tail ends 34 of the drawstring 31during delivery and at least partial retrieval of the closure device 10,as illustrated in FIG. 5. The bioptome 46 may be inserted within thedelivery catheter 50 to grasp the tail ends 34 after the closure device10 is positioned within the distal end of the delivery catheter 50.

It is also within the scope of the present invention for the drawstring31 to extend from the center ring 25 through the proximal end of thedelivery catheter 50 such that a physician, rather than a bioptome, maygrasp the ends of the drawstring 31 during delivery and at least partialretrieval of the closure device 10. The drawstring 31 connecting theproximal and distal occluding bodies 12, 16 and the drawstring extendingthrough the delivery catheter 50 may be the same drawstring 31, in whichcase after deployment of the closure device 10 a cutting instrument isused to snip off the drawstring 31 at a point just proximal the centerring 25. Alternatively, the drawstring extending through the deliverycatheter 50 may be a separate drawstring than the drawstring 31connecting the proximal and distal occluding bodies 12, 16, in whichcase the drawstring extending through the delivery catheter may belooped through the center ring 25 such that removal of the drawstringextending through the delivery catheter 50 merely includes releasing oneend of the drawstring and pulling the other end.

FIGS. 4-5 illustrate deployment of the closure device 10. Duringdeployment, the delivery catheter 50, including the closure device 10 inits collapsed delivery configuration disposed within the distal end ofthe delivery catheter 50, is moved distally through the body opening 9.The distal occluding body 16 is deployed from the distal end of thedelivery catheter 50 distally of the septum 6 and the distal end 42 ofthe body opening 9. The distal occluding body 16 is deployed from thedistal end of the delivery catheter 50 by manipulating at least one ofthe catheter 50 and the center rod 33. For example, a physician may holdthe center rod 33 stationary and retract the delivery catheter 50; thephysician may hold the delivery catheter 50 stationary and advance thecenter rod 33; or the physician may retract the delivery catheter 50 andadvance the center rod 33 to deploy the distal occluding body 16. As thedistal occluding body 16 is released from the constraint of the catheterwall of the delivery catheter 50, it self-expands and retains itsoriginal shape, the eyelets 30 of the distal occluding body 16 thuspulling the drawstring 31 to a larger perimeter. As the distal umbrellaframe 18 returns to its original shape, it pulls the biocompatible sheetmaterial 32 taut.

Preferably, the bioptome 46 grasps the tail ends 34 of the drawstring 31to prevent the expanding distal occluding body 16 from pulling theproximal occluding body 16 out of the catheter 50 via the forceresulting from the tightening of the drawstring 31 caused by theexpansion of the distal occluding body 16. Accordingly, the bioptome 46grasping the tail ends 34 of the drawstring 31 provides an opposingforce which may prevent full expansion of the distal occluding body 16until the bioptome 46 releases the tail ends 34 of the drawstring 31 andthe proximal occluding body 12 is deployed.

Referring to FIG. 5, the delivery catheter 50, including the proximaloccluding body 12 in its collapsed delivery configuration disposedwithin the distal tip of the delivery catheter 50, is retracted throughthe body opening 9. The center rod 33 is likewise retraced with thedelivery catheter 50 through the body opening 9 to move the distaloccluding body 16 proximally to engage the septum 6 at the distal end 42of the body opening 9, and to prevent the proximal occluding body 12from deploying until positioned at the proximal end 40 of the bodyopening 9. Likewise, the bioptome 46 preferably holds its grasp of thetail ends 34 of the drawstring 31 until the proximal occluding body 12is released from the delivery catheter 50. The proximal occluding body12 is deployed from the distal end of the delivery catheter 50proximally of the septum 6 and the proximal end 40 of the body opening 9in the same manner described above with respect to the distal occludingbody 16.

In this embodiment, as the proximal occluding body 12 is released fromthe constraint of the catheter wall of the delivery catheter 50, and thetail ends 34 of the drawstring 31 are released from the grasp of thebioptome 46, the proximal occluding body 12 self-expands and retains itsoriginal shape. As the proximal umbrella frame 14 returns to itsoriginal shape, it pulls the biocompatible sheet material 32 taut. Inthis embodiment, the length of the drawstring 31 connecting the proximaland distal occluding bodies 12, 16 is predetermined such that when thedistal occluding body 16 expands, there is sufficient force to pull theexpanded proximal occluding body 12 distally along the center rod 33 toengage the septum 6 at the proximal end 40 of the body opening 9. Thepredetermined length of the drawstring 31 is preferably dependent uponthe length of the body opening 9 and the distance between the eyelets 30of the distal umbrella frame 18 in the expanded configuration.

As illustrated in FIG. 7, the center rod 33 is formed from twodetachable rod portions, detachable via a screw fit, or any suitablemeans in the art which allows the center ring 25 to seamlessly slidealong the center rod 33. Preferably, the center rod 33 is detachable ata point 36 just proximal the proximal occluding body 12 when in theexpanded delivery configuration. Thus, a portion of the center rod 33remains attached to the distal occluding body 16 and extends justproximally of the proximal occluding body 12 in the expandedconfiguration.

If the physician is satisfied with the position and sizing of theclosure device 10, the detachable portion of the center rod 33 isdetached and the detached portion of the center rod 33, the bioptome 46,and the delivery catheter 50 are withdrawn from the patient. If,however, the physician is not satisfied with the position and/or sizingof the closure device 10, or if the closure device 10 has been deployedimproperly, the closure device 10 is repositionable.

FIG. 6 illustrates the closure device 10 during at least partialretrieval, or repositioning. In this embodiment, the bioptome 46preferably grasps the tail ends 34 of the drawstring 31 and proximallyretracts the drawstring 31 as the center rod 33 is advanced distally.Distally advancing the center rod 33 applies a distal force to thedistal occluding body 16 near its center while proximally retracting thedrawstring 31 applies an opposing proximal force to the distal occludingbody 16 at the eyelets 30 due to the looped drawstring connectionbetween the proximal and distal occluding bodies 12, 16. The combinationof the distal and proximal forces on the distal occluding body 16 causesthe eyelets 30 of the struts 26 to slide inward along the septum 6toward the body opening 9.

As the distal occluding body 16 collapses, the bioptome 46 grasping thetail ends 34 of the drawstring 31 is retracted further and the deliverycatheter 50 is advanced distally. Further retracting the bioptome 46,and thus the drawstring 31, moves the proximal occluding body 12proximally and the distal occluding body 16 proximally via thedrawstring connection between the proximal and distal occluding bodies12, 16. Distally advancing the delivery catheter 50 collapses theproximal frame 14 into its collapsed configuration as the catheter 50receives the proximal occluding body 12. The drawstring 31 is retractedfurther, pulling the distal occluding body 16 towards the distal end ofthe delivery catheter 50 and the delivery catheter 50 is advanced toreceive the distal occluding body 16, eyelets 30 first. In thisembodiment, the physician may redeploy the closure device 10 asdescribed above. Once properly deployed, the physician may detach thecenter rod 33, remove the bioptome 46 and the center rod 33, and removethe delivery catheter 50 from the patient's body.

In a further aspect, the present invention provides a method for closingor occluding a body opening 9 in a patient using the closure device 10or closure device assembly 60 as described above. As depicted in theflow chart in FIG. 8, the method comprises positioning (100) a deliverycatheter 50 within a body opening 9 of a patient, the delivery catheter50 including a closure device 10, as described above, disposed withinthe distal end of the delivery catheter 50 in a collapsed configuration.The method further comprises deploying (102) the closure device 10 fromthe delivery catheter 50 such that the distal occluding body 16 expandsto its expanded configuration and engages the body tissue 6 at thedistal end 42 of the body opening 9 and the proximal occluding body 12expands to its expanded configuration and engages the body tissue 6 atthe opposing proximal end 40 of the body opening 9.

Deploying (102) the closure device 10 includes positioning the deliverycatheter 50 distal to the distal end 42 of the body opening 9 and movingthe delivery catheter 50 and the center rod 33 relative to one anotherto deploy the distal occluding body 16. Deploying (102) the closuredevice 10 further includes positioning the delivery catheter 50 proximalto the proximal end 40 of the body opening 9 and moving the deliverycatheter 50 and the center rod 33 relative to one another to deploy theproximal occluding body 12.

The method for closing or occluding a body opening 9 may furthercomprise repositioning the closure device as described above withrespect to FIG. 6. After the closure device 10 is properly positioned,the method further includes detaching the detachable portion of thecenter rod 33 and removing the detached portion of the center rod 33,the bioptome 46, and the delivery catheter 50 from within the patient.

While the present invention has been described in terms of preferredembodiments, it will be understood, of course, that the invention is notlimited thereto since modifications may be made to those skilled in theart, particularly in light of the foregoing teachings.

1. A method for closing a body opening in a patient comprising:positioning a delivery catheter having a proximal end, a distal end, anda lumen formed through the proximal and distal ends within the bodyopening, the delivery catheter including a closure device collapsiblydisposed within the lumen at the distal end of the delivery catheter,the closure device including a distal occluding body having anexpandable distal umbrella frame and a proximal occluding body having anexpandable proximal umbrella frame, the distal frame including aplurality of struts having first ends attached to a distal end of acenter rod, the proximal frame including a center ring and a pluralityof struts having first ends attached to the center ring, the center ringbeing slidable along the center rod, the struts of each frame beingconnected to a biocompatible sheet material, the center rod defining alongitudinal axis, the distal frame struts extending from the distal endof the center rod in a generally parallel, axial direction with respectto the longitudinal axis when the distal frame is in a collapsedconfiguration and in a generally perpendicular, radial direction withrespect to the longitudinal axis when the distal frame is in an expandedconfiguration, the proximal frame struts extending from the center ringin a generally parallel, axial direction with respect to thelongitudinal axis when the proximal frame is in a collapsedconfiguration and in a generally perpendicular, radial direction withrespect to the longitudinal axis when the proximal frame is in anexpanded configuration, each strut of the distal frame extending fromthe first end and terminating with an eyelet, the closure device furtherincluding at least one drawstring threaded through the eyelets of thedistal frame and through the center ring of the proximal frame toconnect the distal and proximal occluding bodies to one another, the atleast one drawstring extending proximally from the center ring; anddeploying the closure device from the delivery catheter about the bodyopening such that the distal frame of the distal occluding body expandsto its expanded configuration at a distal end of the body opening andthe proximal frame of the proximal occluding body expands to itsexpanded configuration at an opposing proximal end of the body opening.2. The method of claim 1, wherein deploying the closure device from thedelivery catheter includes: positioning the delivery catheter distal tothe distal end of the body opening and moving the delivery catheter andthe center rod relative to one another to deploy the distal occludingbody; and positioning the delivery catheter proximal to the proximal endof the body opening and moving the delivery catheter and the center rodrelative to one another to deploy the proximal occluding body.
 3. Themethod of claim 2, further comprising repositioning the closure deviceincluding: distally advancing the center rod and proximally retractingthe at least one drawstring extending proximally from the center ring toat least partially retrieve the closure device, wherein distallyadvancing the center rod applies a distal force to the distal occludingbody near a center of the distal occluding body, wherein proximallyretracting the at least one drawstring applies an opposing proximalforce to the distal occluding body at the eyelets, the combination ofthe distal and proximal forces on the distal occluding body causing theeyelets of the struts of the distal frame to move inward towards thebody opening collapsing the distal frame; further retracting the atleast one drawstring extending proximally from the center ring anddistally advancing the delivery catheter, wherein further retracting theat least one drawstring extending proximally from the center ring movesthe proximal occluding body proximally and the distal occluding bodyproximally via the at least one drawstring connecting the proximal anddistal occluding bodies, wherein distally advancing the deliverycatheter collapses the proximal frame into its collapsed configurationas the delivery catheter receives the proximal occluding body, whereinthe delivery catheter receives the distal occluding body as the at leastone drawstring extending proximally from the center ring is retractedfurther and the delivery catheter is advanced further; and redeployingthe closure device in a more optimal position within the patient.
 4. Themethod of claim 1, wherein the center rod of the closure device includesa first portion and a detachable second portion, the method furthercomprising withdrawing the delivery catheter from the patient's bodyopening including: detaching the detachable second portion of the centerrod from the first portion at a point proximal to the center ring of theproximal frame when the proximal frame is in its expanded configuration;and withdrawing the detachable second portion of the center rod.
 5. Themethod of claim 1 wherein the body opening is an atrial septal defect ora patent foramen ovale.
 6. The method of claim 1, wherein the bodyopening is defined by surrounding body tissue and includes a distal endand a proximal end, the distal occluding body being configured forplacement outside the body opening to engage body tissue adjacent thedistal end of the body opening, the proximal occluding body beingconfigured for placement outside the body opening to engage body tissueadjacent the proximal end of the body opening.
 7. The device of claim 6,wherein the struts of the distal and proximal frames comprise an arcuateconformation, the struts of the distal frame being biased in a proximaldirection against the body tissue adjacent the distal end of the bodyopening and the struts of the proximal frame being biased in a distaldirection against the body tissue adjacent the proximal end of the bodyopening when the distal and proximal frames are in their expandedconfigurations.
 8. The method of claim 1, wherein the at least onedrawstring includes a single drawstring including a first portionconnecting the distal and proximal frames to one another and a secondportion extending proximally from the center ring.
 9. The method ofclaim 1, wherein the at least one drawstring includes a first drawstringconnecting the distal and proximal frames to one another and a seconddrawstring extending proximally from the center ring.
 10. The method ofclaim 1, wherein the at least one drawstring extending proximally fromthe center ring includes tails ends which extend proximally from thecenter ring, wherein a grasping instrument grasps the tail ends duringdelivery and at least partial retrieval of the closure device.
 11. Themethod of claim 1, wherein the at least one drawstring extendingproximally from the center ring includes first and second ends extendingthrough a delivery catheter, wherein the first and second ends of the atleast one drawstring are grasped by a physician during delivery and atleast partial retrieval of the closure device.
 12. The method of claim1, wherein the biocompatible sheet material is selected from the groupconsisting of DACRON, PTFE, ePTFE, polyurethane, cotton, silk, wool,polyester, and extracellular matrix material.
 13. The method of claim 1,wherein the struts are formed from a material selected from the groupconsisting of superelastic material, stainless steel wire, Nitinol,cobalt chrome-alloys, and cobalt-chromium-nickel-molybdenum-iron alloy.14. The method of claim 1, wherein the at least one drawstringconnecting the distal and proximal occluding bodies to one another has apredetermined length such that expansion of the distal frame to itsexpanded configuration moves the proximal frame distally along thecenter rod.
 15. The method of claim 1, wherein the struts of the distalframe extend from the distal end of the center rod in a direction towardthe proximal occluding body and the struts of the proximal frame extendfrom the center ring in a direction toward the distal occluding bodywhen the distal and proximal frames are in their collapsedconfigurations.